Peri-vascular Adipose Tissue Inflammation Evaluated Using Coronary CT Angiography

  • STATUS
    Recruiting
  • End date
    Jan 20, 2023
  • participants needed
    200
  • sponsor
    University of Leicester
Updated on 9 May 2021

Summary

The P-VECT Study proposes to test the use of CCTA-derived FAI measurements in a group of patients with coronary artery inflammation, who will receive routinely-used statin and aspirin treatment. The P-VECT Study is a pilot study that will provide the rationale and data for power calculations to enable design of pivotal trials of the clinical effectiveness of FAI.

Description

In this research we will study the ability of coronary CT angiography (CCTA)- derived Fat Attenuation Index (FAI) measurements to detect changes in coronary artery inflammation following treatment with atorvastatin and aspirin . CT scan images are used to evaluate the presence of atherosclerotic plaque in the wall of the coronary arteries. The new CCTA technique, FAI, detects and quantifies coronary artery inflammation by analysis of the characteristics of the adipose tissue (fat) around the wall of the artery - the peri-vascular adipose tissue (PVAT) This is a pilot study, involving patients undergoing a clinically indicated CCTA as part of their routine clinical care who are shown (on their scans) to have mild coronary artery plaques (<50% luminal stenosis) with a high FAI value (>70.1 HU). Patients will have 6 visits (one of which screening) with hospital attendance on 3 occasions for blood tests and drug supply. The pilot study will provide the rationale for power calculations from which further studies can be developed to evaluate the clinical effectiveness of FAI.

Details
Condition Cardiovascular Risk Factor
Treatment aspirin and atorvastatin
Clinical Study IdentifierNCT04181749
SponsorUniversity of Leicester
Last Modified on9 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must satisfy the following conditions
Male or Female, aged 30 to 80 years
CCTA scan showing mild coronary artery plaques (<50% luminal stenosis) with a high FAI value (>70.1 HU) within last 3 months
No definite clinical indication for statin treatment (i.e. do not have either cholesterol >6.5 mM, or cholesterol >5.0 mM and QRISK score >10%)
Clinical equipoise for statin and aspirin treatment, as determined by the local treating physician. In these patients, there is clinical equipoise because routine treatment with aspirin and statin is not mandated by current guidelines, but the presence of minor coronary artery plaques is frequently interpreted by clinicians as an indication for aspirin and statin treatment. Accordingly, some patients in this group typically receive aspirin and statin treatment, whereas others do not
Willing and able (in the Investigators opinion) to comply with all study requirements
Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of any incidental findings
Able to understand both verbal or written English
\-

Exclusion Criteria

The participant may not enter the study if ANY of the following are known to apply
Previous documented history of coronary artery disease requiring treatment. This includes any of the following
Acute myocardial infarction Unstable angina Coronary revascularization
procedure Clinically significant coronary artery disease diagnosed by invasive
or non-invasive testing
\. Known diabetes mellitus
\. Definite clinical indication for statin treatment (i.e. has either
cholesterol >6.5 mM, or cholesterol >5.0 mM and QRISK score >10%)
\. Treatment with aspirin, statin or any prescribed lipid modification
therapy in 6 weeks before baseline CCTA
\. Atrial fibrillation (paroxysmal or persistent)
\. History of New York Heart Association (NYHA) Class III or IV heart failure
within the past 12 months of consent
\. Autoimmune disease requiring immunosuppressive therapy or systemic
corticosteroid therapy
\. Active treatment with any anti-inflammatory agents (e.g. NSAIDs
corticosteroids)
\. Active neoplasm requiring surgery, chemotherapy, or radiation within the
prior 12 months (subjects with a history of malignancy who have undergone
curative resection or otherwise not requiring treatment for at least 12 months
prior to screening with no detectable recurrence are allowed)
\. Contraindication for aspirin and/or statin therapy
\. Severe Chronic kidney disease (estimated glomerular filtration rate < 30
mL/min/1.73 m and/or serum creatinine > 2.5 mg/dL or 220 mol/l)
\. Hepatic dysfunction (aspartate aminotransferase [AST] or alanine
aminotransferase [ALT] > 3 the upper limit of normal [ULN] measured on local
labs in last 6 months)
\. Any clinically significant abnormality identified at the time of
screening that, in the opinion of the Investigator, would preclude safe
completion of the study
\. Any other significant disease or disorder which, in the opinion of the
Investigator, may either put the participants at risk because of participation
in the study, or may influence the result of the study, or the participant's
ability to participate in the study
\. Participants who have participated in another research study involving a
treatment intervention or an investigational product, in the past 12 weeks
\. Patients unable to understand verbal or written English
\. Contraindication to contract dye for CCTA
\. Pregnancy
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